UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017283 |
|---|---|
| Receipt number | R000018378 |
| Scientific Title | The correlation of drug concentration and side effect/clinical efficacy in the use of liposomal amphotericin B after hematopoietic cell transplantation |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2024/10/31 20:34:17 |
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Basic information
Public title
The correlation of drug concentration and side effect/clinical efficacy in the use of liposomal amphotericin B after hematopoietic cell transplantation
Acronym
AMB conc. after HCT
Scientific Title
The correlation of drug concentration and side effect/clinical efficacy in the use of liposomal amphotericin B after hematopoietic cell transplantation
Scientific Title:Acronym
AMB conc. after HCT
Region
| Japan |
Condition
Condition
Hematologic disease
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation of drug concentration and side effect/clinical efficacy in the use of liposomal amphotericin B after hematopoietic cell transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Drug concentration of liposomal amphotericin B (trough, peak)
Key secondary outcomes
Side effect and clinical efficacy of liposomal amphotericin B
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients treated with liposomal amphotericin B for invasive fungal infection after allogeneic hematopoietic cell transplantation at Toranomon Hospital or Toranomon Hospital Kajigaya
Key exclusion criteria
Patients who have allergy to amphotericin B or liposomal amphotericin B
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Taniguchi |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
105-0001
Address
2-2-2, Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
taniguchi-s@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Takagi |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
105-0001
Address
2-2-2, Toranomon, Minato-ku, Tokyo, Japan
TEL
03-3588-1111
Homepage URL
shinsuke-takagi@umin.net
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Okinaka Memorial Institute for Medical Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital
Address
2-2-2, Toranomon, Minato-ku, Tokyo, Japan
Tel
03-3588-1111
chiken-jim2@toranomon.gr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38097040/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38097040/
Number of participants that the trial has enrolled
30
Results
C/D ratio was not correlated with age, hepatic function, renal function, or serum albumin. Body weight adjusted C/D ratio was negatively correlated with CRP. Cmax and Cmin were compared between responders and non-responders, those with or without hypokalemia, and those with or without renal impairment. A higher Cmax in patients with hypokalemia was the only significant difference seen.
Results date posted
| 2024 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study population consisted of 30 adult patients who were given L-AMB for a deep mycosis that occurred in the course of treatment of hematological diseases in the Department of Hematology at Toranomon Hospital from May 2015 to September 2018.
Participant flow
L-AMB was given as a daily infusion of 1-8 mg/kg (60-375 mg per patient). Blood samples for determining AMPH-B plasma concentrations were collected at the initiation of infusion (Cmin) and at the end of infusion (Cmax) on a day between Day 3 and Day 250 of L-AMB treatment. The whole blood samples were centrifuged to collect plasma that was stored frozen at -80C until analysis. Blood samples for determining AMPH-B plasma concentrations was sampled on multiple days from 5 of the 30 patients.
Adverse events
The relationship of the status of hypokalemia to AMPH-B plasma concentrations is shown in Fig. 7. Of the 19 patients whose initial potassium was above 3.5 mmol/L, hypokalemia occurred in 10. The mean value of Cmax was significantly higher, at 49.1 +-17.8 ug/mL, in patients who developed hypokalemia compared to 29.9 +-13.2 ug/mL in patients who did not (p =0.02). Cmin was not significantly different in these two groups (p =0.50). Receiver operating characteristic (ROC) curve analysis to determine the Cmax value at which hypokalemia resulted in the optimal cutoff value of 35.6 ug/mL (ROC-AUC =0.82, p =0.02). Eighteen of the patients had impaired renal function after L-AMB treatment and 12 did not. Plasma concentration of AMPH-B, shown as Cmax or Cmin, seems to have no correlation with the renal impairment status (p =0.39 and 0.72, Fig. 8).
Outcome measures
The body weight adjusted C/D ratio and CRP were negatively correlated (p =0.01, Fig. 3). The correlation between the time course of Cmax and Cmin and CRP in the 5 patients whose plasma concentration was determined on multiple days are shown in Fig. 4. In 4 of the 5 patients, plasma concentrations increased as CRP normalized from a high value. When CRP is high (10 mg/dL or more) compared to when it is low (less than 10 mg/dL), Cmax and Cmin increased more briskly when the dose of L-AMB (per unit body weight) increases, as shown in Fig. 5. Plasma concentrations were higher in the low CRP group than in the high CRP group. In all groups, the correlation was higher than that obtained in Fig. 1.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2015 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018378
